In the treatment of urethral syndrome, trigonitis and posterior urethritis, topical application of medicament is the preferred means of treatment. Due to the remote location of the tissues affected by these ailments, however, topical application has heretofore been impossible or ineffective. For example, urethral suppositories used in the past for treatment of these ailments have slipped into the bladder or have been expelled due to internal pressure. The present invention presents a unique design for the gynecological urethral suppository which facilitates topical application of the desired medicament on the urethra itself, as well as on the bladder trigone, the ureters, the periurethra, the urethral meatus and the bladder, while facilitating comfortable retention of the suppository in the urethra during use.
Urethral syndrome is a complex of persistent, irritative lower urinary tract symptoms without evidence of bacteriologic infection or obvious bladder or urethral abnormality. The reported incidence of urethral syndrome among adult women is 20% to 30%. The most common presenting symptoms are urinary frequency, urgency and dysuria; other frequent symptoms include suprapubic pressure, tenderness and dyspareunia. By contrast, urinary incontinence and nocturia are uncommon complaints.
The diagnosis of urethral syndrome is based on the presenting history of chronic, irritating lower urinary tract symptoms without evidence of bacteriologic infection. In the course of physical examination, the external genitalia, urethra, and urethral meatus are inspected. Graduated urethral sounds (available in sizes 12-38 French) may be used to calibrate the urethra. The normal urethra measures 22-28 French. Urodynamic assessment may be included.
Past treatment of urethral syndrome has relied on the administration of oral medication, since effective topical application was impractical due to the remoteness of the affected tissues and the ineffectiveness of past attempts to employ urethral suppositories.
In accordance with the present invention, a urethral suppository is provided that overcomes the difficulties experienced with the past use of oral medication and prior urethral suppositories. The preferred embodiment of the invention comprises a urethral suppository including a bulbous head including a gradually inwardly curved surface that eases insertion of the suppository and an outwardly curved surface that facilitates comfortable retention. The bulbous head further facilitates topical application of medication to the bladder trigone, where the urethra joins the ureters to facilitate passage of urine from the bladder.
The urethral suppository further comprises an enlarged conical tail that facilitates comfortable retention of the urethral suppository, while successfully administering medication to the urethral meatus. The bulbous head and conical tail of the urethral suppository are joined by a narrow shaft which topically applies medicament to the interior wall of the urethra. Preferably, the urethral suppository consists entirely of a medicament that melts or dissolves during the use thereof.
The protocol employing the gynecological urethral suppository herein disclosed will include a seven-day treatment of twice daily insertion of the urethral suppository. The primary treatment for a perimenopausal patient is a urethral suppository comprising one percent Hydrocortisone, 0.007 percent Diethylstilbesterole, and two percent Lydocaine suspended in a base, such as Polyethylene Glycol. Hydrocortisone is included in the medicament in an effort to counteract chronic periurethral gland inflammation and inhibit deposition of collagen in the urethrovaginal septum. Lydocaine is included as a topical anesthetic.